Linical uses Qualio to streamline CRO efforts and help biotech and pharma companies secure regulatory approval
Linical is a global contract research organization (CRO) that provides expertise to pharmaceutical and biotech companies to help them bring drug therapies from the development stage through the clinical trial and regulatory approval processes.
Linical was founded in 2005, is headquartered in Japan, and focuses the bulk of its work on oncology, infectious disease, and CNS research.
As pharmaceutical and biotech research companies scale, they hit an operational ceiling where managing quality and compliance processes with paper-based legacy systems becomes impossible.
This is precisely the position Linical found itself in a few years ago when it merged with fellow CRO Accelovance to grow its global footprint.
Accelovance had had the foresight to implement and apply Qualio as a dedicated electronic quality management system (eQMS) before the merger.
After the unification took place, Linical examined Qualio themselves, liked what they saw, and decided to roll the software out across the entire organization.
In particular, Linical was looking for an eQMS that was easy to use and maintain, familiar to the market and cost-effective. Qualio checked all the boxes.
Linical now has more than 950 global Qualio users, with more added each month to match the company's rapid growth.
We sat down with Tyler Cochran, Executive Director of Quality at Linical Americas who joined the team in July 2020, to hear his thoughts.
Over the course of his career, Tyler has became familiar with some of the larger QMS vendors like TrackWise, Veeva and MasterControl. But in a few short months, Tyler was impressed by the string of tangible operational benefits he unlocked with Qualio:
Having deployed larger solutions at bigger global organizations in the past, Cochran is used to QMS platforms that take a long time to implement and an even longer time for users to get up to speed on.
But the experience was different with Qualio.
When I think about Qualio, the first word that comes to mind is simplicity.
Qualio makes a great first impression. People don’t have the same reaction that I’ve seen with larger, more complex solutions that tend to seem overwhelming.
In previous roles, Tyler faced challenges with document management: both time-heavy manual processes, and suboptimal solutions from other eQMS software vendors.
But with Qualio, Tyler and his team were able to intuitively understand the system, build and manipulate documents, and send them for approval in quick, repeatable and controlled cycles.
Review cycles, review processes, and just getting documents into the system all required a dedicated document manager's time.
That’s not necessary with Qualio.
Tyler found the primary benefit of Qualio came with the newfound ease of passing internal and external audits, driven by the ease and simplicity of their new electronic quality management system.
You can get any document you need very quickly and present it an auditor in a matter of minutes - compared to other systems that require long, drawn-out processes that are not necessarily as quick or friendly.
You can look at an SOP in Qualio, see the list of associated documents, and click hyperlinks to retrieve information immediately. That’s one feature I’m greatly enjoying.
Hyperlinks, not found in the other QMS solutions Tyler had used in the past, combined with Qualio's easy-to-use interface and information management to provide the Linical team with a cogent, controlled and compliant single source of truth.
